Patient leaflet - Equilis Te
B. PACKAGE LEAFLET
PACKAGE LEAFLET FOR Equilis Te suspension for injection for horses
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1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT
Intervet International B.V.
Wim de Korverstraat 35
5831 AN Boxmeer
The Netherlands
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2. NAME OF THE VETERINARY MEDICINAL PRODUCT
Equilis Te suspension for injection for horses
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3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
Each dose of 1 ml contains:
Active substance:
Tetanus toxoid 40 Lf 1
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1 Flocc ulation equivalents; corresponds with > 30 lU/ml guinea pig serum in the Ph. Eur. potency test
Adjuvants:
Purified Saponin 375 tig
Cholesterol 125 tig
Phosphatidylcholine 62.5 tig
A clear opalescent suspension.
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4. INDICATION(S)
Active immunisation of horses from 6 months of age against tetanus to prevent mortality.
Onset of immunity: 2 weeks after the primary vaccination course
Duration of immunity: 17 months after the primary vaccination course
24 months after the first revaccination
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5. CONTRAINDICATIONS
None.
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6. ADVERSE REACTIONS
A diffuse hard or soft swelling (max. diameter 5 cm) may rarely occur at the injection site, regressing within 2 days. In very rare cases a local reaction exceeding 5 cm and possibly persisting longer than 2 days may occur. Pain at the injection site can occur in rare cases which may result in temporary functional discomfort (stiffness). In very rare cases, fever, sometimes accompanied by lethargy and inappetence, may occur for 1 day, and up to 3 days in exceptional circumstances.
The frequency of adverse reactions is defined using the following convention:
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– very common (more than 1 in 10 animals displaying adverse reaction(s) during the course of one treatment)
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– common (more than 1 but less than 10 animals in 100 animals)
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– uncommon (more than 1 but less than 10 animals in 1,000 animals)
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– rare (more than 1 but less than 10 animals in 10,000 animals)
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– very rare (less than 1 animal in 10,000 animals, including isolated reports).
If you notice any serious effects or other effects not mentioned in this package leaflet, please inform your veterinary surgeon.
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7. TARGET SPECIES
Horses
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8. DOSAGE FOR EACH SPECIES, ROUTE AND METHOD OF ADMINISTRATION
Intramuscular use
Vaccination schedule:
Primary vaccination course
Administer one dose (1ml), by intramuscular injection, according to the following schedule:
- Primary vaccination course: first injection from 6 months of age, second injection 4 weeks later
Revaccination
The first revaccination is given not later than 17 months after the primary vaccination course.
Thereafter a maximum interval of two years is recommended (see scheme).
| V1 V2 5 ,___________________12________________V3___________________24 | V4 |
| 0 1 6 18 Equilis Te Equilis Te Equilis Te | 42 months Equilis Te |
In case of increased infection risk or insufficient colostrum intake, an additional initial injection can be given at the age of 4 months followed by the full vaccination programme (primary vaccination course at 6 months of age and 4 weeks later)
Concurrent active and passive immunisation (emergency vaccination)
The vaccine can be used together with Tetanus-Serum for treatment of injured horses that have not been immunised against tetanus. In that case, the first dose (V1) of vaccine can be given concurrently with the appropriate prophylactic dose of Tetanus-Serum at a separate injection site, using separate syringes and needles. This will lead to a passive protection against tetanus for at least 21 days after concurrent administration. The second dose of the vaccine (V2) should be administered 4 weeks later. A third vaccination with Equilis Te should be repeated at least four weeks later. Concurrent use of Equilis Te and Tetanus-Serum from Intervet may reduce active immunity against tetanus compared to horses vaccinated with Equilis Te in the absence of tetanus antitoxin serum.
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9. ADVICE ON CORRECT ADMINISTRATION
Allow the vaccine to reach room temperature before use.
Administer 1 ml of vaccine intramuscularly.
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10. WITHDRAWAL PERIOD
Zero days.
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11. SPECIAL STORAGE PRECAUTIONS
Keep out of the sight and reach of children.
Store in a refrigerator (2°C –8°C).
Protect from light. Do not freeze.
Do not use this veterinary medicinal product after the expiry date which is stated on the label.
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12. SPECIAL WARNING(S)
Special warnings for each target species:
Foals should not be vaccinated before the age of 6 months, especially when born to mares that were revaccinated in the last two months of gestation, because of possible interference by maternally derived antibodies.
Special precautions for use in animals:
Only healthy animals should be vaccinated.
Special precautions to be taken by the person administering the veterinary medicinal product to animals: In case of accidental self-injection, seek medical advice immediately and show this package insert or the label to the physician.
Pregnancy and lactation:
Can be used during pregnancy and lactation.
Interaction with other medicinal products and other forms of interaction:
Safety and efficacy data are available which demonstrate that this vaccine can be administered on the same day but not mixed with Tetanus Serum from Intervet (see section 8).
No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product except the product mentioned above. A decision to use this vaccine before or after any other veterinary medicinal product therefore needs to be made on a case by case basis.
Incompatibilities:
Do not mix with any other veterinary medicinal product.
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13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY
Ask your veterinary surgeon how to dispose of medicines no longer required. These measures should help to protect the environment.
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14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED
Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency ).
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15. OTHER INFORMATION